Efficacy and Safety of LX101 for Inherited Retinal Dystrophy Associated With RPE65 Mutations
Condition(s) studied
Investigational drug(s) / intervention(s)
LX101: Subretinal administration of LX101 to the study eye
Study summary
The purpose of the study is to evaluate the efficacy and safety of LX101 in subjects with biallelic RPE65 mutation-associated inherited retinal dystrophy. This is an open-label, multicenter, randomized controlled Phase III clinical trial. Subjects were randomly assigned in a 1:1 ratio to either the intervention group or the control group. Subjects in the intervention group received subretinal injection of LX101, while those in the control group received no treatment.
Eligibility
Primary outcome measure(s)
- Mobility Test — 12 months
Changes in functional vision from baseline, determined by mobility test score
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| Zhongshan Ophthalmic Center, Sun Yat sen University | Guangzhou | Guangdong | |
| Southwest Hospital of AMU | Chongqing | China | |
| Shanghai General Hospital | Shanghai | China | |
| Tianjin Medical University Ophthalmology Hospital | Tianjin | China |
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07054632 on ClinicalTrials.gov ↗ ← All trials in China